PMA P210034
- Device
- Agili-C
- Applicant
- Smith and Nephew, Inc.
- PMA number
- P210034
- Product code
- QRU
- Decision date
- 2026-06-04
- Generic name
- Implant, resorbable, for articular osteochondral repair
- Approval order statement
- Approval for updated package labeling that incorporates the clinical results from the required postapproval study.
Current openFDA PMA Record#
- Device
- Agili-C
- Applicant
- Smith and Nephew, Inc.
- PMA number
- P210034
- Supplement
- S001
- Product code
- QRU
- Generic name
- Implant, resorbable, for articular osteochondral repair
- Decision date
- 2026-06-04
- Decision code
- APPR
- Date received
- 2025-12-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updated package labeling that incorporates the clinical results from the required postapproval study.